Nov 4, 2011

FDA approves Octagam's return in the United States

Octapharma issued today a press release announcing that the U.S. Food and Drug Administration (FDA) approved the return of Octagam 5% in the United States. Last year, Octapharma had initiated a voluntary market withdrawal of Octagam in the U.S. in response to an observed increase in thromboembolic events (TEEs). Octapharma reports that the FDA approval was based on changes Octapharma has made in the Octagam 5% manufacturing process and the company’s decision to implement a quality control test on every batch of the product that is released to the marketplace More information on this subject can be found here

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